- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288470
A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
March 17, 2015 updated by: Genzyme, a Sanofi Company
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale
Exclusion Criteria:
- pregnant/lactating women
- patients who previously received permanent facial implants or using ovet-the-counter products
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Non-inferiority as compared to standard of care as assigned by blinded reviewer.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Study Completion
August 1, 2003
Study Registration Dates
First Submitted
February 7, 2006
First Submitted That Met QC Criteria
February 7, 2006
First Posted (Estimate)
February 8, 2006
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYLA-001-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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